SHILEY

Additional Manufacturer Narrative

MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

Description of Event or Problem

IT WAS REPORTED THAT AFTER INDUCTION OF ANESTHESIA, THE ENDOTRACHEAL INTUBATION WAS SUCCESSFULLY COMPLETED ON THE FIRST ATTEMPT. BILATERAL LUNG VENTILATION WITH THE WHITE CUFF WAS NORMAL. THE PATIENT WAS THEN REPOSITIONED FROM THE SUPINE POSITION TO THE LEFT LATERAL POSITION. AFTER SUCCESSFUL POSITIONING WITH A FIBEROPTIC BRONCHOSCOPE, SINGLE-LUNG VENTILATION WAS INITIATED WITH THE BLUE CUFF INFLATED, BUT AIR LEAKAGE WAS DETECTED. THE DEPTH OF THE TUBE WAS ADJUSTED AGAIN, BUT LEAKAGE PERSISTED. THE PATIENT WAS THEN RETURNED TO THE SUPINE POSITION, AND THE TUBE WAS REMOVED AND INSPECTED, CONFIRMING AIR LEAKAGE FROM THE TUBE. ANOTHER TUBE WAS INSERTED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.